Comfort Assist Insulin Syringe

GUDID 00070030510695

.3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct

L PERRIGO COMPANY

Insulin syringe/needle, basic

• Primary Device ID: 00070030510695
• NIH Device Record Key: a8022522-ff4d-4d6a-8121-6c1e7f67b7b7
• Commercial Distribution Discontinuation: 2017-12-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Comfort Assist Insulin Syringe
• Version Model Number: 032912
• Company DUNS: 006013346
• Company Name: L PERRIGO COMPANY
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 0.3 Milliliter
• Total Volume: 0.3 Milliliter
• Total Volume: 0.3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00070030510695 [Primary]
GS1	10070030510692 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062702

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-10
• Device Publish Date: 2016-09-24

On-Brand Devices [Comfort Assist Insulin Syringe]

• 00070030510770: 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510763: .5cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510756: .3cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510749: 1cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510732: .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510725: .3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510718: 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510701: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct
• 00070030510695: .3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 10ct